Kornimate/medical-research-clean huggingface dataset:
study to assess the safety, tolerability, effects on the body, absorption, distribution and elimination of 25 mg bay2433334 in renal impairment including renal replacement therapy ("dialysis")

Conditions: Prevention of Thromboembolic Events

Summary: bay2433334 is under clinical development for prevention of complications in diseases such as heart attack, irregular heart beat or stroke which can arise by formation of blood clots elsewhere in the body and travels through the blood stream to plug another vessel. renal impairment which co-occurs in elderly and patients with heart attack, irregular heart beat or stroke is a common condition in which the kidneys are not filtering the blood as well as they should. the goal of the study is to learn more about the safety of bay2433334, how it is tolerated and the way the body absorbs, distributes and gets rid of the study dug given as a single oral dose of 25 mg tablet in participants with renal impairment and healthy participants matched for age-, gender-, and weight.


Eligibility criteria:
inclusion criteria: * all participants: ≥18 years, male or female (non-wocbp only), bmi 18-35 kg/m² (inclusive); no increased risk of bleeding or common causes of bleeding, no liver dysfunction; no cyp3a4 inhibitors/inducers; * participants with reduced kidney function including those on kidney replacement therapy ("dialysis"): stable disease stratified by renal function (mild, moderate, severe, esrd), no recent cardiovascular events; * age-, gender- and weight-matched participants: normal kidney function, stable and well controlled hypertension and dyslipidemia acceptable, no medications influencing the coagulation system. exclusion criteria: subjects with renal impairment * acute renal failure or active nephritis. * known impaired hepatic function. * history of definite myocardial infarction or cerebrovascular accident within the six months prior to the screening visit. * history of vascular surgery or intervention (e.g., coronary artery bypass, percutaneous transluminal angioplasty etc.) less than 6 months prior to dosing. * congestive heart failure of new york heart association grade iii or iv, severe arrhythmia requiring antiarrhythmic treatment. * any other disease or condition which could influence the physiological metabolic turnover (e.g., endocrine diseases, severe infections). age-, gender, weight matched subjects - history of relevant diseases of vital organs or systems (e.g., of the central nervous system or other systems or organs) with the exception of mild, well controlled hypertension, dyslipoproteinemia and thyroid disorders.

Keywords: renal impairment hemodialysis
pilot and feasibility trial of a telehealth dietary intervention for ms

Conditions: Multiple Sclerosis

Summary: this project aims to determine the feasibility of delivering a comprehensive behavioral lifestyle intervention including dietary and exercise components via an evidence based, internet-delivered telehealth coaching platform. further, investigators will gather preliminary data on the change in multiple sclerosis clinical outcomes and cardiometabolic risk factors after participation in the intervention. the outcomes will inform the design of a larger randomized controlled trial.


Eligibility criteria:
inclusion criteria: 1. relapsing-remitting multiple sclerosis 2. on disease modifying treatment for 6 months 3. no relapse within the previous 30 days 4. self-identify as not currently meeting recommendations for healthy diet and physical activity 5. ambulatory with or without assistance 6. reliable access to the internet via computer or smartphone 7. be responsible for their personal food preparation or have input into the food prepared for them exclusion criteria 1. unstable cardiovascular disease 2. unstable renal disease 3. unstable pulmonary disease 4. physician does not approve participation

Keywords: diet ms telehealth
icf in secondary prevention of cardiovascular disease

Conditions: Cardiovascular Diseases; Secondary Prevention; Risk Factor, Cardiovascular

Summary: the aim of this study was to develop a practical protocol based on the icf(the international classification of functioning, disability, and health) the risk factors of cardiovascular disease (cvd) in secondary prevention.

the original icf assessment sheet contains cvd risk factor categories, such as comorbidities (depressive disorders, insomnia, heart rhythm and heart rate disorders, carotid artery disease, and hypertension), measures of liver and renal impairment, disorders of carbohydrate and lipid metabolism). the evaluation criteria for each category were determined based on recommendations defined in the esc, aha, efsd, and kidigo guidelines.

Eligibility criteria:
inclusion criteria: * the first episode of ischemic stroke or hemorrhagic stroke, * full medical documentation with a description of the above-mentioned risk factors exclusion criteria: * another neurological disease: brain tumor, trauma craniocerebral * incomplete medical history - no data on assessed risk factors cvd
dose-finding study of pdc31 in patients with primary dysmenorrhea

Conditions: Dysmenorrhea

Summary: the purpose of this study is to determine a safe and effective dose range for intravenous administration (infusion) of pdc31 by determining the maximum tolerated dose of pdc31 in patients with primary dysmenorrhea.

this is an open-label, multi-centre, dose-escalating first-in-human phase i study of pdc31 in patients with primary dysmenorrhea aimed at determining the maximum tolerated dose (mtd) of pdc31 in this patient population.

Eligibility criteria:
inclusion criteria: * otherwise healthy females with a history of primary dysmenorrhea * using effective birth control excluding intrauterine contraceptive device (iucd) * must be 18 years of age or older * must give written informed consent to participate in this study exclusion criteria: * patients with an intrauterine contraceptive device or using oral contraceptives within 3 months of treatment in this study * patients with confirmed pelvic inflammatory disease, endometriosis or adenomyosis * patients who are pregnant or who test positive at baseline or are at risk of becoming pregnant while on study * patients who are breastfeeding * patients with hepatic or renal function tests greater than the upper limit of normal and deemed clinically significant by the investigator at screening * patients with a clinically significant medical or psychiatric disorder or a serious medical conditions within the past 6 months which in the opinion of the investigator, should prohibit participation in this study * patients who have been exposure to any investigational drug within 4 weeks prior to screening

Keywords: open label dose-finding phase 1 study
onychomycosis: diagnosis and prevalence in diabetic neuropathic patients

Conditions: Prevalence of Onychomycosis; Diabetic Neuropathic Patients; Diagnostic of Onychomycosis; Patients Clinically Suspected of Onychomycosis; Reliability of the Diagnosis of Onychomycosis

Summary: the prevalence of onychomycosis among diabetic patients is still a debated question as well as the best way to diagnose the disease. we conducted a prospective study to assess the prevalence of onychomycosis in diabetic neuropathic (dn) patients clinically suspected of this disease and to assess the reliability of the diagnosis of onychomycosis.

from december 2000 to january 2005, we followed 100 successive diabetic patients, type 1 and type 2, suffering from (dn). at baseline we assessed age, gender, medical history and medications, foot insensitivity defined by a vibration perception threshold (vpt) \>25 volts and onychomycosis by clinical diagnosis. multiple samples of the most affected nail, often the big toe, were taken. a potassium hydroxide (koh) test was done by 2 independent and blinded investigators and a culture in a laboratory (lab) specialized in mycology. pictures of the nails and particularly of the sampled nail were taken. apart from the laboratory results, two independent and blinded dermatologists gave their diagnosis looking at the pictures.

Eligibility criteria:
inclusion criteria: * inclusion criteria were: presence of diabetes mellitus, type 1 or type 2, age between 18 and 80 years, neuropathy demonstrated by a vpt (vibration perception threshold) \>25 volts tested with a neurothesiometer (horwell scientific, london, uk) and a clinical diagnosis of onychomycosis. exclusion criteria: * exclusion criteria were a history of psoriasis, systemic antifungal therapy during the year preceding the enrolment, immunosuppression either by disease or treatment induced.

Keywords: onychomycosis diabetic neuropathic patients reliability of the diagnostic of onychomycosis
effectiveness of kinesio taping on balance in patients with stroke

Conditions: Stroke

Summary: the aim of this study is to investigate the long term effects of kinesio taping applied on ankle and peroneal muscle in patients with stroke.

stroke is a common neurological problem and is one of the major causes of disability and death (1,2). in stroke patients, the mortality rate is approximately 30%, and there is an increase in the morbidity rate after stroke occurrence. in addition, stroke is one of the main factors in increases in the burden of health care expenses during adulthood (3). there is a constant requirement for specific data about stroke rehabilitation methods for achieving evidence-based rehabilitation guidelines.to investigate the effects of repeated correction taping applied on the ankle and peroneus longus and peroneus brevis muscles on balance and gait in patients with stroke. therefore, the aim of this study is to assess the long term effect of kt applied on ankle and peroneal muscle on both dynamic and static balance in patients with stroke.

Eligibility criteria:
inclusion criteria: * willing to participate * diagnosed with stroke * mini-mental state test score equal or above 25 * modified ashworth scale score lover then 3 * able to walk 10 meter independently exclusion criteria: * secondary neurological diseases * cognitive problems

Keywords: athletic tape proprioception hemiplegia gait
get with the guidelines atrial fibrillation registry

Conditions: Atrial Fibrillation; Atrial Flutter

Summary: get with the guidelines-atrial fibrillation is designed to assist hospital care teams in consistently providing the latest evidence-based treatment for their afib patients. at the same time, it offers a means of monitoring the quality of afib care in u.s. hospitals and building a database for continued research and further quality improvement.

get with the guidelines-atrial fibrillation was initiated in 2013 with over 88 u.s. hospitals participating is designed to assist hospital care teams in consistently providing the latest evidence-based treatment for their afib patients. at the same time, it offers a means of monitoring the quality of afib care in u.s. hospitals and building a database for continued research and further quality improvement. achievement measures tracked through get with the guidelines-atrial fibrillation: 1. acei/arb at discharge for lvsd 2. assessment of thromboembolic risk factors 3. beta blocker at discharge 4. discharged on fda-approved anticoagulation therapy 5. pt/inr planned follow-up 6. statin at discharge in af patients with cad, cva/tia or pvd. quality measures tracked through get with the guidelines-atrial fibrillation: 1. aldosterone antagonist at discharge 2. atrial fibrillation patient education 3. anticoagulation therapy education 4. cha2ds2-vasc reported 5. discharge heart rate \<110bpm 6. smoking cessation 7. warfarin at discharge for valvular atrial fibrillation additional measures collected by get with the guidelines-atrial fibrillation can be viewed at: http://www.heart.org/idc/groups/heart-public/@private/@wcm/@hcm/@gwtg/documents/downloadable/ucm_451183.pdf

Eligibility criteria:
inclusion criteria: * patients hospitalized with nonvalvular atrial fibrillation or atrial flutter exclusion criteria: * patients who do not have nonvalvular atrial fibrillation or atrial flutter * patients under 18 years of age * patients not admitted as inpatients. * patients on comfort care only * patients discharged to hospice.
gw815sf for chronic obstructive pulmonary disease (chronic bronchitis, emphysema)

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: this study evaluates the safety of medicine on copd (chronic obstructive pulmonary disease). this study will last up to 56 weeks, and subjects will visit the clinic 16 times. subjects will be given breathing tests, and will record their breathing symptoms daily on diary cards.


Eligibility criteria:
inclusion criteria: * diagnosis of copd. exclusion criteria: * diagnosis of asthma or an uncontrolled medical condition or respiratory disorder other than copd. * other inclusion and exclusion criteria will be evaluated at the first study visit.

Keywords: chronic bronchitis copd emphysema
spinal anesthesia using lidocaine and sufentanil and (transient neurological symptoms) tns

Conditions: Transient Neurologic Symptoms

Summary: the purpose of this study is to find out whether patients receiving spinal anesthesia containing lidocaine and sufentanil get transient neurological symptoms.


Eligibility criteria:
inclusion criteria: * adults over the age of seventeen years exclusion criteria: * patient refuse spinal anesthesia * spinal anesthesia is contraindicated * pregnancy * patient is incapable of giving consent * diabetes * neurological disorders * chronic pain * chronic use of analgesics * spinal anesthesia within five days before the actual surgery

Keywords: tns spinal anesthesia lidocaine
safety and tolerability study of rn564 in women with osteopenia and healthy men.

Conditions: Osteopenia; Osteoporosis; Bone Disease

Summary: the purpose of this study is to determine the safety and tolerability of rn564 in women with osteopenia and healthy men.


Eligibility criteria:
inclusion criteria: * diagnosis of osteopenia for women (bmd t-scores between -1.0 and - 2.5 sd at the lumbar spine, the femoral neck or total hip) * body mass index (bmi) of 17.5 to 30.5 kg/m2; and a total body weight \>45 kg (99 lbs). * have at least 3 vertebral bodies in the l1-l4 region and one femoral neck site that are accessible by dxa. exclusion criteria: * evidence or history of any underlying condition, other than primary osteopenia, that affect bone metabolism (eg, hyperparathyroidism, hypoparathyroidism). * subjects with pre-existing periodontal/dental disease or those who have undergone invasive dental procedures (eg, tooth extraction, oral surgery) within 60 days prior to day -1. * if qtcf exceeds 455 msec, the ecg should be repeated two more times and the average of the three qtcf values should be used to determine the subject's eligibility.

Keywords: phase 1 osteopenia rn564
detection of neonatal bradycardia

Conditions: Apnea; Bradycardia

Summary: apnea-bradycardia is a frequent phenomenon in preterm infants which has been associated with short term complications and alterations in neurodevelopment. duration and amplitude of the bradycardias depend on the time delay between the beginning of the bradycardia and the intervention of the nurse. the purpose of the study is to test a new method set for early detection of bradycardia in preterm infants.

apnea-bradycardia is a frequent phenomenon in preterm infants which has been associated with short term complications and alterations in neurodevelopment. duration and amplitude of the bradycardias depend on the time delay between the beginning of the bradycardia and the intervention of the nurse. the purpose of the study is to test in clinical units and in real life a new method set for early detection of bradycardia in preterm infants. each preterm infant cardio-respiratory traces will be recorded during two 4-hours periods of time (the first one at the time of occurrence of apnea-bradycardias and the second one during the following week). during those periods, the alarms of the monitors usually used in the units will also be recorded through automatic detection and these alarms will be compared with the alarms generated by the algorithm tested, for false positive and precocity of the detection. a false positive alarm is a detection which is not associated with a bradycardia of less than 80 bpm. the system will be considered efficient if it allows an earlier detection of severe bradycardias without increasing the number of false positive detection.

Eligibility criteria:
inclusion criteria: * parents informed consent * presenting with at least 2 significant apnea bradycardia (apnea + decrease in heart rate of more than 33% during at least 4 sec) exclusion criteria: * postnatal age of less than 4 days * mechanical ventilation * severe neurological lesion

Keywords: apnea-bradycardias preterm infants
evaluation of a new organization for collecting pre-chemotherapy session information

Conditions: Colorectal Neoplasms

Summary: the primary objective of this study is to compare an experimental organization for chemotherapy session planning based on early, standardized, and prioritized means of data transmission via secure e-mail (laboratory results) and the use of a smart phone (for clinical toxicity data) compared to the regular organization, in terms of the rate of prescriptions of chemotherapy prepared at the latest the day before a session and then administered in full (over a 6-month observation period) among colorectal cancer patients in need of cancer treatment in an outpatient setting.

compare the two arms of the study in terms of: a. each element contributing to the primary criterium; b. the quality of chemotherapy related care; c. logistics; d. patient satisfaction with respect to support for chemotherapy care; e. the feasibility and acceptability of the organization by patients will be assessed by the rate of optimal use of toxicity collection tools and patient satisfaction rates relative to the tool (experimental arm) f. comparison of the overall cost of care in both arms and estimated cost of the strategy

Eligibility criteria:
inclusion criteria: * the patient was informed about the implementation of the study, its objectives, constraints and patient rights * the patient has given his/her informed and signed consent * the patient must be insured or beneficiary of a health insurance plan * the patient is available for 6 months of follow-up * the patient is treated via anti-cancer chemotherapy for colorectal cancer * the patient is starting a new adjuvant or metastatic chemotherapy protocol with a follow-up in a day-clinic setting * the patient has already used a smartphone, or desires to learn how, or is accompanied by a person who can help the patient use a smartphone * the anticipated chemotherapy treatment corresponds to one of the following protocols: cetuximab, folfiri, folfiri-aflibercept, folfiri-bevacizumab, folfiri-cetuximab, folfiri-panitumumab, folfirinox, folfirinox-bevacizumab, folfoxiri, folfoxiri-bevacizumab, folfox 4 simplified, folfox 4 simplified - bevacizumab, folfox 4 simplified - cetuximab, folfox 4 simplified - panitumumab, irinotecan-cetuximab, lv5fu2 simplified, panitumumab, xelox. exclusion criteria: * the patient is participating in another study, or has participated in another study within the past 3 months, that may influence the results or conclusions of the present trial * the patient is in an exclusion period determined by a previous study * the patient is under judicial protection, or is an adult under guardianship * the patient refuses to sign the consent * it is impossible to correctly inform the patient * the patient is pregnant, parturient, or breastfeeding * the planned chemotherapy regimen includes weekly treatment cycles * patient who is incapable of using a smartphone either by himself/herself or via another helping person
the effect of kangaroo care on parents' perceived parenting self-efficacy, infant attachment and newborn vital signs

Conditions: Kangaroo Care; Fathers; Mother-Infant Interaction; Premature Infant

Summary: this study was planned to determine the effect of kangaroo care applied by parents of premature newborns in the neonatal intensive care unit on the newborn's vital signs, perceived parenting self-efficacy level and attachment to the baby.

the research is a randomized controlled trial and an experimental research design will be used. the research will be carried out with two groups as experimental (newborns given kangaroo care by both mother and father) and control (newborns given kangaroo care only by the mother) groups.

Eligibility criteria:
inclusion criteria: * parents who volunteered to participate in the research * parents who are turkish citizens and speak turkish * preterm baby born between 28-37 weeks staying in the neonatal intensive care unit * the mother and father do not have any obstacles in taking care of the kangaroo. * mothers and fathers who can come to the hospital regularly on the specified days will be included in the study. exclusion criteria: * not volunteering to participate in the research * parent's inability to speak turkish * presence of a life-threatening major malformation or serious perinatal complication in the premature baby * babies with umbilical catheters and central venous catheters will not be included in the study.

Keywords: kangaroo care